DEVICE: DV8® Retractor (00860222000406)
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Device Identifier (DI) Information
DV8® Retractor
14075150
Not in Commercial Distribution
14075150
Manual Surgical Sciences, L. L. C.
14075150
Not in Commercial Distribution
14075150
Manual Surgical Sciences, L. L. C.
The DV8® Retractor Esophageal Balloon (DV8 Retractor) is a non-sterile, single-use, disposable esophageal balloon retractor. The DV8 Retractor is deployed orally and inflated inside the esophagus. The retractor gently and effectively retracts the esophagus to create a stable operating field.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| Yes | |
| Yes | |
| Yes | |
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| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 62204 | Intraluminal oesophageal retractor |
A hand-held manual instrument intended to be orally introduced into the oesophagus during thoracic surgery to mechanically divert the oesophagus away from the site of surgery, to facilitate surgical site access and to help prevent injury. It is available in a variety of forms (e.g., curved metal wire, metal rod with balloon). This is a single-use device.
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FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| GAD | Retractor |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Balloon Diameter: 14 Millimeter |
| Balloon Length: 230 Millimeter |
Device Record Status
755809f3-d634-474d-b7b5-a3da574b6b6f
March 10, 2026
2
June 13, 2023
March 10, 2026
2
June 13, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
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| No Secondary DIs found | |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined